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Health product recall

Cepacol Extra Strength Cherry

Starting date:
February 20, 2013
Posting date:
April 2, 2013
Type of communication:
Drug Recall
Subcategory:
Drugs, Natural health products
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-26473

Recalled Products

  1. Cepacol Extra Strength Cherry

Reason

Stability failure at the 18-month time point for free benzocaine potency.

Depth of distribution

Distributed to wholesalers and retailers across Canada.

Affected products

A. Cepacol Extra Strength Cherry

DIN, NPN, DIN-HIM
NPN 80032140
Dosage form
  • Lozenge
Strength
  • 4-Aminobenzoic acid, ethyl ester 15.0mg
  • L-Menthol 3.6mg
Lot or serial number
  • AG376
  • AH387
  • AK063
  • AL368
Companies
Recalling Firm
Reckitt Benckiser Ltd.
8020 Esquesing Line
Milton
L9T 6W3
Ontario
CANADA
Marketing Authorization Holder
Reckitt Benckiser Ltd.
8020 Esquesing Line
Milton
L9T 6W3
Ontario
CANADA

Date modified: